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The Division of Hematology in the Department of Medicine has an outstanding opportunity for a full-time Research Manager.
The purpose of this position is to promote the clinical research objectives of the Division of Hematology. This position works with Division of Hematology faculty to facilitate investigator-initiated and pharmaceutical-sponsored clinical trials, identify research problems and design hypotheses to be tested. This position is responsible for managing the research team and independently implementing multiple research projects.
This position is constantly required to integrate information from multiple sources to ensure that all research proposals meet the requirements of the University, the Food and Drug Administration, the National Institutes of Health and the study sponsor. This position develops procedures that ensure that all research meets or exceeds these requirements while expeditiously furthering the research objectives of the Division of Hematology. There are multiple resources available within the University system (e.g. Grant and Contract Services, Institutional Review Board, Office of Industry Relations) to help in this process, but ultimately, the work must be done independently and in a resourceful manner to expedite the Division’s research objectives. This position is also responsible for organizing and facilitating sponsor-initiated, FDA-initiated, and institution-initiated audits of study data. Finally, this position interacts with representatives from federal and state agencies, foundations, pharmaceutical companies, health care providers and cancer patients in a manner that well-represents the University of Washington and its associated institutions (FHCRC and SCCA).
Must be able to work independently on multiple research projects without benefit of written policies or procedures. This position requires daily interaction with sponsors, physicians, the U.S. Food and Drug Administration, other health care personnel (e.g. nurses, patient care coordinators, insurance companies), and patients.
This position directly manages the Hematology clinical research staff, which currently includes 6 research coordinators, a regulatory coordinator and 2 finance staff, providing supervision, management and leadership within the clinical research program for the division of Hematology. This position also establishes and maintains policies and procedures for our clinical research program and the management of clinical trials within the guidelines of the Federal Drug Administration (FDA), institutional policies, HIPAA and Good Clinical Practices.
The position interviews candidates, hires research staff, documents exit interviews, documents research staff human resource actions, such as letter of expectations, requests for dismissals and generates effective solutions that meet the needs of all parties involved. Meets regularly with staff individually and in small groups to facilitate delegation, direction, and prioritization of the program's responsibilities. This position works closely with the Division’s human resource manager, Dept. of Med. human resource and UW Central human resource to ensure positions and issues are resolved professionally and in a timely manner.
Oversees compliance with protocol management for both sponsor initiated and investigator initiated clinical trials this includes procedures that meet research objectives and ensure compliance with all aspects of Institution, FDA, and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects (e.g. investigator financial disclosure requirements of the FDA). Direct staff as they develop, document and maintain procedures for patient registration and protocol implementation to ensure that research execution meets Good Clinical Practice (GCP) guidelines. Directs the design, creation and revision of research instruments (e.g. case report forms, AE logs, Study guides) as necessary to ensure quality data that satisfies research objectives. Oversees the research staff create and maintain complete source documentation for patients on studies. Oversees the Regulatory Coordinator to ensure that reporting to the Institutional Review Board and Study Sponsors are timely, accurate and satisfy applicable regulation and that all regulatory documents are submitted to meet timelines. Provide guidance, develop and implement corrective action plans to ensure protocol adherence and data integrity. Oversee that monitoring visits are scheduled according to the contracts. Serve as protocol expert for assigned studies. Oversee study start-up process, regulatory, quality assurance/data and finance to ensure studies are implemented and run in a timely manner and in a way which is successful, and compliant with Institutional, Industrial and Federal regulations, guidelines, and standards.
Communicate budget guidelines ensure overall fiscal compliance of each study. Recommend budget changes in accordance to clinical trial needs. Collaborate with program finance team and Program Operations Manager to identify and implement strategies to mitigate areas of financial risk.
Provide expert guidance to research staff in regard to contract terms, informed consents, payment terms, sponsor invoicing, budget tracking, final reports to sponsors, and closing budgets.
The vision of the Division of Hematology is to “achieve and maintain national and regional leadership in Hematologic and translational research”. This position assures that programmatic strategic plan aligns with and supports the division of Hematology. Cody has set up program meetings about our burgeoning research endeavors to create new and differing discussions regarding our clinical trials. Has assisted with disseminating the multiple programs progress across the Cancer Consortium, as well as facilitating Consortium support of the benign Hematologic clinical trials. Cody lead and supervised an initiative with the "AML treatment plans" which resulted in a "Process/Systems Improvement award from the University of Washington.
As a UW employee, you will enjoy generous benefits and work/life programs. For detailed information on Benefits for this position, click here.
Bachelor’s Degree in Health-related field and 3-5-year relevant experience.
Excellent written and verbal communication skills, experience with Microsoft Office.
Previous experience working with oncology patients.
Previous experience with database development.
Previous experience in clinical research project coordination, knowledge of FDA and NIH requirements relating to research involving human subjects, experience in clinical trial development, implementation and analysis.
Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to complete it within 30 days of hire.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
Applicants should be highly motivated and energetic and while remaining personable, professional and organized under potentially stressful situations.
Previous experience developing and negotiating clinical research budgets.
CONDITIONS OF EMPLOYMENT
This position requires a flexible work schedule. Stringent deadlines from sponsors and faculty for protocol implementation and data collection may require overtime. Integrating required elements of research into complex patient schedules (e.g collecting and processing multiple blood specimens for pharmacokinetic sampling) may also require occasional overtime.
Must be available to enroll patients and maintain email/pager contact with 24/7 availability. Some evening and weekend travel to study meetings and sites may be required.
Application Process: The application process for UW positions may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process. These assessments may include Workforce Authorization, Cover Letter and/or others. Any assessments that you need to complete will appear on your screen as soon as you select “Apply to this position”. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment you will be prompted to do so the next time you access your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.
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